NCT02156921

Brief Summary

This study aims to investigate the cost-effectiveness of app-based self-directed ultrasound training compared to self-directed training with written handouts on subsequent performance on simulated patient cases and theoretical cases.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

May 27, 2014

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 5, 2014

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

October 27, 2016

Status Verified

October 1, 2016

Enrollment Period

1 month

First QC Date

May 27, 2014

Last Update Submit

October 26, 2016

Conditions

Learning OutcomeTraining Efficiency

Outcome Measures

Primary Outcomes (2)

  • Video recording of ultrasound skills, rated by consultant radiologists.

    The video-recordings of the technical performances are merged with the ultrasonography screen-recordings to one anonymized video-clip. These combined video-clips are rated with the OSAUS rating by two raters. The OSAUS scale (Objective Structured Assessment of Ultrasound Skills) is used for all performance assessments. The raters are consultant radiologists.

    Ratings are to be completed within three months of performance.

  • Cost-effectiveness of mobile app guided versus textbook guided training

    September 2016

Secondary Outcomes (1)

  • Diagnostic accuracy

    On site via checklist, evaluated on average one day after performance.

Study Arms (2)

Control group

NO INTERVENTION

Self-guided training without app-based training (written hand-outs)

Intervention group

ACTIVE COMPARATOR

Self-guided training with app-based training

Other: App-based training

Interventions

App-based trainingOTHER
Intervention group

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • First year medical doctor
  • Provided written informed consent

You may not qualify if:

  • Prior practical ultrasonography experience such as performing independent ultrasonography scans, or participation in any post-graduate ultrasonography courses.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Copenhagen Academy for Medical Education and Simulation

Copenhagen, Capital Region, DK-2100, Denmark

Location

Study Officials

  • Philip M Nilsson

    Copenhagen Academy Of Medical Education And Simulation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

May 27, 2014

First Posted

June 5, 2014

Study Start

May 1, 2014

Primary Completion

June 1, 2014

Study Completion

October 1, 2015

Last Updated

October 27, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)